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  5. Label Information: Antacid

FDA Label for Antacid

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH 5 ML) (ONE TEASPOONFUL)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS

Antacid Product Label

The following document was submitted to the FDA by the labeler of this product Rij Pharmaceutical Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each 5 Ml) (One Teaspoonful)



Aluminum Hydroxide (Equi. to Dried Gel, USP) 225 mg

Magnesium Hydroxide 200 mg

Simethicone 25 mg


Purpose



Antacid

Antigas


Uses



relieves

  • •heartburn
  • •acid indigestion
  • •sour stomach
  • •associated symptoms of gas and upset stomach
  • •pressure and bloating commonly referred to as gas

Warnings



Do not take more than 12 teaspoonfuls in a 24-hour period or use the maximum dosgae for more than 2 weeks. Except under the advise and supervision of a physician.


Ask A Doctor Before Use If You Have



  • •kidney disease
  • •a magnesium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are



taking a prescription drug. Antacids may interact with certain prescription drugs.


Stop Use And Ask A Doctor If



symptoms last for more than 2 weeks


Keep Out Of Reach Of Children.



In case of accidental overdose, get medical help or contact a Poison Control Center immediately.


Directions



  • •shake well before each use
  • •Adults and children 12 years and older, take 2 to 4 teaspoonsful between meals, at bedtime or as directed by a physician
  • •do not take more than 12 teaspoonsful in 24 or use the maximum dosage for more than 2 weeks
  • •Children under 12 years: consult a physician

Other Information



  • •TAMPER EVIDENT: DO NOT USE IF BREAKAWAY BAND ON CAP IS BROKEN OR MISSING
  • •Store at room temperature 15° - 30°C (59° - 86°F)
  • •keep tightly closed
  • •protect from freezing
  • •each teaspoon (5 mL) contains: magnesium 83 mg
  • •each teaspoon (5 mL) contains: sodium 1 mg
  • •does not meet USP requirements for preservative effectiveness

Inactive Ingredients



flavors, hypromellose, parabens, saccharin, sodium hypochlorite, sorbitol, water and xanthan gum


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